Trial Outcomes & Findings for Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy (NCT NCT04475679)

NCT ID: NCT04475679

Last Updated: 2025-02-04

Results Overview

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-02-04

Participant Flow

The recruitment period took place between 14.09.2020-30.06.2021 in the clinic.

Participant milestones

Measure	Adhese Universal DC Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Adhese Universal DC n=40 Participants Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=40 Participants Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth	Total n=80 Participants Total of all reporting groups
Age, Customized 18-65 years	40 Participants n=40 Participants	40 Participants n=40 Participants	80 Participants n=80 Participants
Sex: Female, Male Female	13 Participants n=40 Participants	15 Participants n=40 Participants	28 Participants n=80 Participants
Sex: Female, Male Male	27 Participants n=40 Participants	25 Participants n=40 Participants	52 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline (7-10 days)

Population: Baseline

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=39 Inlays/Onlays Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=39 Inlays/Onlays Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 FDI 11 (Postoperative hypersensitivity), FDI Score 1	39 Inlays/Onlays	38 Inlays/Onlays
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 FDI 11 (Postoperative hypersensitivity), FDI Score 2	0 Inlays/Onlays	1 Inlays/Onlays
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 FDI 11 (Postoperative hypersensitivity), FDI Score 3-5	0 Inlays/Onlays	0 Inlays/Onlays

PRIMARY outcome

Timeframe: 12 months

Population: Baseline

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=37 Inlays/Onlays Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=36 Inlays/Onlays Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 FDI 11 (Postoperative hypersensitivity), FDI Score 1	37 Inlays/Onlays	36 Inlays/Onlays
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 FDI 11 (Postoperative hypersensitivity), FDI Score 2	0 Inlays/Onlays	0 Inlays/Onlays
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 FDI 11 (Postoperative hypersensitivity), FDI Score 3-5	0 Inlays/Onlays	0 Inlays/Onlays

SECONDARY outcome

Timeframe: Baseline

assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=40 restored teeth Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=40 restored teeth Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 Vitality, FDI Score 1	40 restored teeth	40 restored teeth
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 Vitality, FDI Score 2-5	0 restored teeth	0 restored teeth

SECONDARY outcome

Timeframe: Baseline

assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=40 restored Teeth Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=40 restored Teeth Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 FDI 13 (Tooth Integrity), FDI Score 1	40 restored Teeth	40 restored Teeth
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 FDI 13 (Tooth Integrity), FDI Score 2-5	0 restored Teeth	0 restored Teeth

SECONDARY outcome

Timeframe: Baseline

assessed on patient teeth (checking inlays/onlays for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=40 Inlays/Onlays Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=40 Inlays/Onlays Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 Fracture of material and retention, FDI Score 5	1 Inlays/Onlays	1 Inlays/Onlays
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 Fracture of material and retention, FDI Score 1	39 Inlays/Onlays	38 Inlays/Onlays
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 Fracture of material and retention, FDI Score 2	0 Inlays/Onlays	0 Inlays/Onlays
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 Fracture of material and retention, FDI Score 3	0 Inlays/Onlays	1 Inlays/Onlays
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 Fracture of material and retention, FDI Score 4	0 Inlays/Onlays	0 Inlays/Onlays

SECONDARY outcome

Timeframe: Baseline

assessed on the patient teeth (looking for marginal gaps/Fractures, checking outlines) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=39 Inlays/Onlays Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=39 Inlays/Onlays Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 Marginal Quality, FDI Score 1	37 Inlays/Onlays	37 Inlays/Onlays
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 Marginal Quality, FDI Score 2	2 Inlays/Onlays	2 Inlays/Onlays
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 Marginal Quality, FDI Score 3-5	0 Inlays/Onlays	0 Inlays/Onlays

SECONDARY outcome

Timeframe: 12 months

assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=40 restored teeth Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=40 restored teeth Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 Vitality, FDI Score 1	40 restored teeth	40 restored teeth
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 Vitality, FDI Score 2-5	0 restored teeth	0 restored teeth

SECONDARY outcome

Timeframe: 12 months

assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=40 restored teeth Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=40 restored teeth Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 FDI 13 (Tooth Integrity), FDI Score 1	40 restored teeth	40 restored teeth
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 FDI 13 (Tooth Integrity), FDI Score 2-5	0 restored teeth	0 restored teeth

SECONDARY outcome

Timeframe: 12 months

assessed on patient teeth (checking inlays/onlays for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=40 Inlays/Onlays Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=40 Inlays/Onlays Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 Fracture of material and retention,FDI Score 1	37 Inlays/Onlays	36 Inlays/Onlays
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 Fracture of material and retention,FDI Score 2-4	0 Inlays/Onlays	0 Inlays/Onlays
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 Fracture of material and retention,FDI Score 5	3 Inlays/Onlays	4 Inlays/Onlays

SECONDARY outcome

Timeframe: 12 months

assessed on the patient teeth (looking for marginal gaps/Fractures, checking outlines) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	Adhese Universal DC n=37 Inlays/Onlays Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface	Adhese Universal n=36 Inlays/Onlays Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 Marginal Quality, FDI Score 1	37 Inlays/Onlays	36 Inlays/Onlays
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 Marginal Quality, FDI Score 2-5	0 Inlays/Onlays	0 Inlays/Onlays

Adverse Events

Adhese Universal DC

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adhese Universal

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Adhese Universal DC n=40 participants at risk Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth surface	Adhese Universal n=40 participants at risk Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth
Product Issues Retention Loss	7.5% 3/40 • Number of events 3 • 1 year An adverse event was defined as something unfavourable that happened to the treated tooth and was reported as part of the regular recall by the investigator. (either technical AE such as fracture of the treated tooth or restoration/tooth replacement and retention loss of the restoration/tooth replacement, or biological AE such as post-operative sensitivity and secondary caries on the treated tooth)	10.0% 4/40 • Number of events 4 • 1 year An adverse event was defined as something unfavourable that happened to the treated tooth and was reported as part of the regular recall by the investigator. (either technical AE such as fracture of the treated tooth or restoration/tooth replacement and retention loss of the restoration/tooth replacement, or biological AE such as post-operative sensitivity and secondary caries on the treated tooth)

Additional Information

Team Leader Study Management

Ivoclar Vivadent AG

Phone: +4232353780

Email: patrizia.elkuch-hoch@ivoclar.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place